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Work Package 1: Project Management

 

WP1 has been set the objective of providing the Alliance with an overall scientific and governance structure that will facilitate collaboration, support, and effective supervision among all our partners. Such a clear statement of goals and expected outcomes will ensure the quality and timeliness of deliverables and that the project’s objectives are effectively managed.


Objectives


WP1 Partners

AEMPS, Amgen, AP-HP, Barts Health, Bayer, BfArM, Celgene, EAPM, EBMT, EHA, ELN, EORTC, Erasmus MC, ERIC, FisM Onlus, GFM, GMV, Goethe University, GPOH, GRAALL, GRL-SANGER, HHU, HULAFE, IECSCYL-IBSAL, IJC, Janssen, LeukaNET, LMU, LYSA, MediSapiens, MediUni Wien, Menarini, MML, MU, Newcastle University, NICE, Novartis, OPBG, SYNAPSE, Takeda, UCAM, Ulm University, UNIBO, UNITO, University of Helsinki, University of Navarra, University of Rome Tor Vergata, University of York, VHIO, VIB, VUMC.


Achievements WP1

Achievements 2018:

  • Greatly supported and coordinated other WPs interactions, being particularly present at key multidisciplinary tasks such as the definition of outcomes and establishment of a safe data anonymisation procedure.
  • Negotiated agreements with over 50 European institutions that have expressed their desire to join HARMONY as Associated Members; this has resulted in the acceptance of 13 new Associated Members in 2018 and the signature of 11 AM data sharing agreements. Additionally, coordinated the data sharing of 6 HARMONY Partners, among which 1 EFPIA member. 
  • Kept HARMONY’s Ethics Advisory Board and Expert Advisory Panel duly informed on the progress of the project, and implemented their advice in the relevant frameworks. 
  • Fostered, implemented and dynamized the procedure for the submission and approval on bench-to-bedside research proposals;
  • Coordinated the preparation of IMI paperwork: amendments to HARMONY's framework documents (Consortium and Grant Agreements), “Periodic technical report (annual scientific and financial reports) , and deliverables established for 2018.
     

Achievements 2017:

  • Established the Ethics Advisory Board and External Advisory Panel. Reference to the advisors for the development of HARMONY’s “modus operandi” on data privacy and the establishment of ties with other international initiatives;
  • Coordinated and aligned on a common terminology: HARMONY and re-use of data;
  • Developed a procedure for the submission and approval on bench-to-bedside research proposals;
  • Developed of the legal framework for data sharing with Associated members: Associated Members’ Engagement Framework and Associated Members’ Data Sharing Agreement;
  • Contacted 55 Associated Members. Positive reply and AMEF signed from 14 organizations. Another 19 organizations on signature process;
  • Made agreements with industry partners for sharing published clinical trial data in existing bench-to-bedside projects;
  • Coordinated activities, the development of management internal procedures and the adjustment to changes: submitted the first amendment;
  • Submitted deliverables to the Innovative Medicine Initiative, funder of the HARMONY Alliance.

Outlook

WP2 will continue to focus on: